BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABREVA CONCEAL

    MDR report key: 3070199 · Received April 16, 2013

    Report

    Report Number
    3008395004-2013-00002
    Event Type
    Other
    Date Received
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ABREVA CONCEAL IS MANUFACTURED IN (B)(4) AND NEITHER THE PRODUCT NOR LOT NUMBER FOR THIS PRODUCT WAS AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF APPLICATION SITE INFECTION IN A (B)(6) FEMALE PATIENT WHO RECEIVED CLASS 1 MEDICAL DEVICE (ABREVA CONCEAL) OINTMENT FOR PRODUCT USED FOR UNKNOWN INDICATION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNKNOWN DATE, THE PATIENT STARTED CLASS 1 MEDICAL DEVICE (UNKNOWN) AT UNKNOWN DOSING. AT AN UNKNOWN TIME AFTER STARTING CLASS 1 MEDICAL DEVICE, THE PATIENT EXPERIENCED APPLICATION SITE INFECTION, COLD SORES, CONDITION AGGRAVATED, AND PRODUCT COMPLAINT. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENTS WAS UNKNOWN. AE'S REPORTED VIA EMAIL RECEIVED (B)(4) 2013. CONSUMER REPORTED AFTER USING THE PRODUCT TWICE IT MADE HER COLD SORE WORSE. CONSUMER REPORTED SHE HAD A HUGE PUS POCKET THAT WASN'T THERE WHEN SHE PUT THE PATCH ON AND CONSUMER REPORTED WHEN SHE REMOVED THE PATCH, THE PUS CAME OUT AND HER COLD SORE WAS OOZING ALL DAY. CONSUMER REPORTED PRODUCT COMPLAINT OF THE PATCHES NOT STICKING. (B)(4). ALL FUTURE CORRESPONDENCE WILL BE SUBMITTED TO (B)(4). THE FOLLOWING INFORMATION WAS EXTRACTED FROM CASE (B)(4). AE RECEIVED VIA E-MAIL (B)(4) 2013: CONSUMER REPORTED A PRODUCT COMPLAINT OF ADHESION DESCRIBED AS, TO GET THEM TO STICK, YOUR LIP HAS TO BE COMPLETELY DRY, AND PUS AT APPLICATION SITE WHICH WAS DESCRIBED AS, I FINALLY GOT ONE TO STICK AND IT WAS ONLY ON FOR 1.5 HOURS AND THERE WAS A HUGE PUS POCKET UNDERNEATH IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163280 ABREVA CONCEAL CLASS 1 MEDICAL DEVICE KGX GLAXOSMITHKLINE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other